The FDA’s proposed new labeling requirements for generics pose such a challenge to industry that GPhA has asked the FDA for an additional two months to comment on the proposed rule.
GPhA says more time is needed to analyze and provide commentary on the legal and commercial implications of the rule change, which would allow generics makers to change labeling without FDA approval in response to safety concerns.
Current rules allow generic drugmakers to update labeling only as a means of conforming with changes made to the brand-referenced drug’s label. This has largely shielded generic makers from injury suits.
The proposed rule nullifies a 2011 Supreme Court decision in the case of Pliva v. Mensing, in which the court rejected the notion that generic companies have an obligation to request label changes after new adverse events were found, Daniel Kracov, a partner at Arnold & Porter, says.
If the rule is finalized, generic drugmakers will need specific evidence to fend off lawsuits that claim the drugmaker failed to warn about serious side effects, because the courts could find them liable in the same way they have found brand drugmakers liable for years, Kracov said.
The proposed rule would present a host of business issues, as well, he said, noting that most generic drugmakers don’t currently have systems in place to analyze adverse event reports for signals that would prompt a labeling change.
Shortly after the proposed rule was issued last month, GPhA questioned whether the agency has the authority to issue the rule in the wake of the court’s decision. The group also said it is concerned that multiple generic drugmakers could file conflicting safety information for the same generic product, leading to “unnecessary confusion and uncertainty for prescribers and patients.”